The patient population for a phase II trial often consists of multiple subgroups with different prognosis. In this case, a popular design approach is to specify the response rate and the prevalence of each subgroup, to calculate the response rate of the whole population by the weighted average ...
Optimal two-stage designs for phase II clinical trialsclinical trialsphase II trialsoptimizationThe primary objective of a phase II clinical trial of a new drug or regimen is to determine whether it has sufficient biological activity against the disease under study to warrant more extensive ...
The first stage of the design aims to explore the toxicity profile. The second stage aims to find the OBD, which can achieve the optimal therapeutic effect by considering both the toxicity and efficacy outcomes through a utility function. The closed‐form estimates and concise dose‐finding ...
The primary objective of a phase II clinical trial of a new drug or regimen is to determine whether it has sufficient biological activity against the disea... R Simon 被引量: 1709发表: 0年 Balanced two-stage designs for phase II clinical trials BACKGROUND: Oncology phase II clinical trials...
Simon's Two-Stage Design is a type of phase II clinical trial. It is one of the most common multi-stage designs used in Phase IIa clinical trials. The Simon two-stage design is an exact design which allows flexibility regarding the null and alternative hypotheses while also allowing stopping...
NOV-002 in combination with doxorubicin and cyclo- phosphamide followed by docetaxel in patients with HER-2 negative clinical stage II-IIIc breast cancer... AJ Montero,CM Diaz-Montero,YE Deutsch,... - 《Breast Cancer Research & Treatment》 被引量: 78发表: 2011年 Phase I/II study of G313...
Since the publication of the first issue of Nature Reviews Clinical Oncology, we have witnessed advances in multiple research areas that have culminated in improved outcomes for many cancer types, although substantial unmet needs remain for a majority of
Simon’s two-stage designs [1] are commonly used in phase II clinical trials, especially in cancer clinical trials. In a study with a Simon’s design, the null hypothesis is concerned with a response rate, H 0:π≤π 0. The power is calculated at some π 1>π 0. A Simon’s desig...
The primary objective of a phase II clinical trial of a new drug or regimen is to determine whether it has sufficient biological activity against the disea... R Simon - 《Controlled Clinical Trials》 被引量: 4190发表: 1989年 Asymptotic efficiency of the two-stage estimation method for copula...
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic ...